October 1, 2020
FDA Approves Expanded Indication for Medtronic’s Resolute Onyx DES for 1-Month DAPT in High-Bleeding-Risk Patients
October 1, 2020—Medtronic announced it has received FDA approval for new 1-month dual antiplatelet therapy (DAPT) labeling with an expanded indication for patients at high bleeding risk (HBR) implanted with the company’s Resolute Onyx drug-eluting stent (DES) in the United States.
The approval is based on results from the Onyx ONE Clear Study, which evaluated approximately 1,500 complex HBR patients on 1-month DAPT who were treated with Resolute Onyx. At 1 year, the study met its primary endpoint of cardiac death or myocardial infarction and showed Resolute Onyx to be safe and effective in HBR patients on 1-month DAPT.
According to the company, Resolute Onyx DES and its biocompatible polymer and stent design have been shown in clinical studies to promote fast vessel healing and be well suited for patients who may benefit from a DAPT duration as short as 1 month. It has been proven safe and effective using a 1-month regimen of DAPT after a percutaneous coronary intervention (PCI) in HBR patients, who compose approximately 40% of PCI patients, including older patients, those with history of bleeding, or those on oral blood-thinning drugs.
In May, the Resolute Onyx received European CE Mark approval for a 1-month DAPT indication for HBR patients in Europe.
On March 30, the company announced that the Onyx ONE Clear study met its primary endpoint by beating a performance goal derived from contemporary 1-month DAPT trials at 1-year postprocedure. Ajay Kirtane, MD, Principal Investigator for the Onyx One Clear study, presented the results at ACC.20/WCC Virtual, the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology.
Dr. Kirtane, who is Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons in New York, New York, commented in Medtronic’s announcement, “It is so rewarding to see the efforts of those involved in examining the safety and efficacy of 1-month DAPT following PCI—the coordinators, investigators, and most importantly the Onyx ONE Clear patient participants—come to fruition with this new HBR indication for the Resolute Onyx DES. It is remarkable how the combination of technology innovation, in conjunction with the generation of clinical evidence, has informed our understanding that shorter durations of DAPT may in fact be safe in appropriately selected patients treated with Resolute Onyx DES.”